SII Seeks DCGI Nod For Market Authorisation Of Covid Vaccine

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Pune: The Serum Institute of India (SII) has sought the drug regulator’s approval for market authorisation of its COVID-19 vaccine Covovax as a booster dose for those aged 18 years and above who have been administered two doses of Covishield or Covaxin, official sources said on Thursday.

Prakash Kumar Singh, director, government and regulatory affairs, SII, submitted a market authorisation application for the heterologous booster dose of Covovax to the drugs controller general of India (DCGI) on October 17.

It has been learnt that the DCGI’s office had raised a few queries, after which Singh submitted a reply, mentioning about the current emerging situation caused by a new coronavirus variant.

Covovax was approved by the DCGI for a restricted emergency use in children aged seven to 11 years in June.

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